Immix Biopharma, Inc. announced presentation of additional AL Amyloidosis clinical data from its Phase 1b/2a NEXICART-1 (NCT04720313) study of novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, NXC-201, at an oral presentation at the 20th International Myeloma Society Annual (IMS) Meeting being held in Athens, Greece on September 27-30 2023. Data were presented from 9 relapsed/refractory AL amyloidosis patients (including one new patient) in the ongoing Phase 1b/2aNEXICART-1 study of NXC-201 (formerly HBI0101). The Phase 1b portion of the ongoing phase 1b/2a clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells.

The expected primary endpoint for the Phase 2 portion of the ongoing Phase 1b/2a clinical trial of NXC-201 in relapsed/refractory multiple myeloma is overall response rate and duration of response. ImmixBio subsidiary Nexcella plans to submit data to the FDA in multiple myeloma once 100 patients are treated with NXC-201. NXC-201 has the potential to be the world's first out-patient CAR-T and has been awarded Orphan Drug Designation (ODD) by the FDA in both multiple myeloma and AL Amyloidosis.

The lead Tissue Specific Therapeutic (TSTx) asset, IMX-110, is in Phase 1b/2a clinical trials as a monotherapy and IMMINENT-01 (NCT05840835) combination clinical trial with BeiGene's anti-PD-1 antibody tislelizumab. NXC-201 has been awarded ODD and Rare Pediatric Disease Designation (RPDD) by the FDA.